Z-1340-2015Class II
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet...
Microtek Medical LLC / initiated 2015-03-10 / Terminated / root cause: labeling and UDI
Microtek Medical Inc began a recall of FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel... on . FDA classified it as Class II and gives the reason as "This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1340-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Microtek Medical LLC
- Product
- FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
- Product code
- FYA Gown, Surgical
- Reason for recall
- This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
- Root cause tag
- labeling and UDI
- FDA root cause
- Error in labeling
- Action
- The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: [email protected] RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email; [email protected].
- Quantity in commerce
- 11 units
- Distribution
- US (nationwide) Distribution.
- Product codes and lots
- Lot Numbers: C9272 and C10078
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1337-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1338-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1339-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1340-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1341-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1342-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1343-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1344-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1345-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1346-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1347-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1348-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1349-2015 | Class II | Terminated | Voluntary: Firm initiated |
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